Chronic Fatigue Syndrome Clinical Trial
Official title:
Effect of Probiotic Food Supplement "GutMagnific™" in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Also Known as Post-viral Fatigue Syndrome, and Comorbid Gastrointestinal Complications
Verified date | October 2021 |
Source | ImmuneBiotech Medical Sweden AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a neurological disease. Currently there is no effective treatment for ME/CFS due to unclear etiology of the disease. The aim of this randomized double-blind placebo-control clinical trial is to study the efficacy of the probiotic food supplement "GutMagnific™" in ME/CFS and comorbid gastrointestinal complications. The outcome of the study will be assessed based on the data from different self-reporting questionnaires and intestinal microbial flora analysis.
Status | Completed |
Enrollment | 74 |
Est. completion date | June 30, 2021 |
Est. primary completion date | March 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Clinical diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) at Stora Sko¨ndals Neurological Rehabilitation Clinic - Gastrointestinal complications similar to IBS Exclusion Criteria: - Consumption of any probiotics two weeks before enrolment - Consumption of other probiotic products during the trial |
Country | Name | City | State |
---|---|---|---|
Sweden | Neurological Rehabilitation Clinic in Stora Sköndal | Stockholm |
Lead Sponsor | Collaborator |
---|---|
ImmuneBiotech Medical Sweden AB | Karolinska Institutet |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in ME/CFS symptoms | ME/CFS symptom rating scale filled up weekly by participants, graded 0-4 to evaluate degree of disease burden, according to the diagnostic Canadian Criteria. Higher score indicating worse outcome. | At the baseline and weekly for 4 months | |
Secondary | Changes in Irritable Bowel Syndrome (IBS) symptoms | Questionnaire for IBS filled up by participants, graded 1-10 to evaluate degree of different bowel symptoms. Higher score indicating better condition. | At the baseline and weekly for 4 months | |
Secondary | Changes in the gastrointestinal symptoms based on Rome III criteria | Rome III questionnaire for IBS filled up by participants | At the baseline and after 3 & 4 months | |
Secondary | Changes in health related quality of life (RAND 36-Item Health Survey) | RAND-36 questionnaire for health-related quality of life filled up by participants. The questionnaire evaluating eight health concepts: physical functioning, role limitations caused by physical health problem, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Possible score is 0 (lowest) to 100 (highest) for each item. | At the baseline and monthly for 4 months | |
Secondary | Changes in Hospital Anxiety and Depression Scale (HADS) | HADS questionnaire for anxiety and depression filled up by participants.The questionnaire comprises questions for anxiety and depression. Each item on the questionnaire is scored from 0-3 and means that a person can score between 0 and 21 for either anxiety or depression. Higher score representing worse outcome. | At the baseline and after 3 & 4 months | |
Secondary | Changes in gut microbiota composition | Fecal samples will be analysed using sequencing-based methods to monitor possible changes related to probiotic treatment. Samples taken prior to and after probiotic treatment in the same participant will be compared. | At the baseline and after 3 months |
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